The FDA has approved a device that can deliver a single monthly injection of evolocumab (Repatha), the cholesterol-lowering PCSK9 inhibitor manufactured by Amgen.
Repatha is currently administered by subcutaneous injection in a 140-mg dose every 2 weeks or as a 420 mg monthly dose. Until now, the monthly dose has been given in the form of three consecutive injections. The Pushtronex system is an on-body infusor with a prefilled cartridge of evolocumab.
Amgen said that the device adheres to the body and is hands-free. While receiving the injection, patients are able to perform moderate physical activities. The system was developed in collaboration with West Pharmaceutical Services.
Repatha is indicated to lower LDL cholesterol as an adjunct to diet and maximally tolerated statin therapy for people with either heterozygous or homozygous familial hypercholesterolemia or with established atherosclerotic cardiovascular disease. The U.S. wholesale acquisition cost of Repatha is $14,100, although the actual cost is often lower.
The only other PCSK9 inhibitor on the market, alirocumab (Praluent) is administered every 2 weeks and is available in 75 mg or 150 mg and is available in the form of a single-dose prefilled pen or syringe.
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